Injectable products by SCA Pharmaceuticals: Recall — potential contamination.
ISSUE:
SCA Pharmaceuticals LLC is voluntarily recalling various lots of injectable products to the hospital level. The is a potential for the products to contain microbial contamination. See the recall notice for a full list of products.
BACKGROUND:
Administration of a drug product, intended to be sterile, that may contain microbial contamination has the potential to result in serious adverse events which may include life-threatening infections. SCA Pharmaceuticals has not received any customer complaints or reports of adverse events related to this issue.
RECOMMENDATION:
SCA Pharmaceuticals is notifying its customers via telephone, email and U.S. mail and is arranging for return/replacement of all recalled products. Customers that have product which is being recalled, as indicated in the list, should discontinue use immediately and return the product to SCA Pharmaceuticals.
Consumers with questions regarding this recall can contact SCA Pharmaceuticals at 877-550-5059, between the hours of 8:00 am and 5:00 pm (Central), Monday through Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Click here to read the MedWatch safety alert, along with a link to the current press release.
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(Source: FDA MedWatch)
